• Korean Journal of Biological Psychiatry
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• v.4 no.1
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• pp.127-131
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• 1997

Objective : To evaluate the clinical efficacy of adjuvant sertraline treatment in chronic schizophrenic patients, we carried out a double-blind, placebo controlled study. Method : Thirty six inpatients who fulfilled DSM-III-R criteria for chronic schizophrenia were randomly assigned to sertraline and placebo groups in a double-blinded fashion. A history of at least 2 years of illness and at least six months of hospitalization were prerequisities for inclusion in the study. Patients were received sertraline 50mg or placebo for 8 weeks in addition to their routine haloperidol regimen. Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression(CGI), Simpson-Angus Scale(S-A) were evaluated at 5 points ; baseline, 2, 4, 6, and 8 weeks of treatment. Results : The groups were controlled for age, gender, and length of illness. There were no significant differences in three PANSS factros(positive, negative, general), CGI, and S-A scale scores at any between sertaline and placebo treatment. Conclusion : This placebo controlled study showed no significant effects of sertraline on negative and positive symptoms in chronic schizophrenic patients.

• Journal of Acupuncture Research
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• v.20 no.2
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• pp.145-160
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• 2003

Objective : This study was designed to find out whether placebo auricular acupuncture is able to be constituted as an appropriate control group for needle insertion to Korean. Methods : We performed a randomized controlled, single-blind study(n=48) comparing subjective evaluations of needles insertion and avoidance of needles insertion. Both ears were needled concurrently, one real acupuncture(needle insertion) and the other placebo acupuncture(avoidance of needle insertion with blunt tip). Subjects then completed a questionnaire rating the intensity of five sensations in each ear, and also attempted to identity which ear received placebo and which ear received real acupuncture. Results : As for the effects of real and placebo acupuncture on each item(Warmth, Fullness, Pain, Activity, Radiating), real acupuncture was significantly warmer, fuller, more painful than placebo acupuncture. In particular, the real acupuncture only in experienced acupuncture recipients was significantly warmer, fuller, more painful than placebo acupuncture. About the ability to differentiate real and placebo acupuncture, 54.2 percent correctly identified which ear received real acupuncture and which ear received placebo acupuncture. However, the ability to differentiate real and placebo acupuncture for naive and experienced acupuncture recipients was not significantly different. Conclusions : Most of the subjects(Korean) identified which ear received placebo and which ear received real acupuncture. We found that this placebo auricular acupuncture is not able to be applied to Korean, in particular for experienced acupuncture recipients. Further study is needed for new placebo auricular acupuncture or racial difference between American.

• Journal of Physiology & Pathology in Korean Medicine
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• v.22 no.1
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• pp.234-245
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• 2008

Yeonkyopaedok-san(YPS) extract is widely used to treat the common cold. The purpose of this study was to evaluate the efficacy of YPS on the common cold. Two hundred Patients with common colds of recent onset were randomized to the double blind, placebo-controlled study. They received 800 mg YPS extract or placebo in capsules, orally dissolved 3 times a day for 7 days. The total symptom score was assessed by the physician, using a 5-point scale on start and finish. Resolution of cold symptoms based on subjective daily symptoms. Total symptom score was significantly decreased in YPS groups in comparison to that in placebo group (p=0.027). Headache (p=0.012), loss of appetite (p=0.037), eyeball discomfort (p=0.002) were more affected. Time to resolution of cold symptoms did not show significant effect (p=0.592). Adverse effects were less in the YPS group than placebo group (2% vs 3%). In this community-based, randomized controlled trial, YPS were effective in treating cold symptoms in college students.

• Korean Journal of Acupuncture
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• v.35 no.2
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• pp.47-55
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• 2018

Objectives: Clinical improvements can be observed following placebo administrations in clinical trials. Randomized controlled trials have been conducted to disentangle the specific effects of therapeutic interventions over the past decade. In acupuncture trials, non-penetrating placebo needles offer the opportunity to determine the specific effects of needling. Methods: The present review provides an overview of the concept of the placebo effect and the characteristics of the placebo needles. Results: Placebo control can contribute to minimize for bias and the contextual and psychological components of therapeutic interventions. Placebo control should meet two criteria: blinding efficacy (indistinguishable from active treatment) and physiological inertness. In the case of acupuncture, however, it is difficult to meet both criteria simultaneously. The dilemma of placebo needles suggests that placebo needles do not constitute proper control in acupuncture research. Considering the characteristics of placebo needles, patients are more likely to perceive placebo needles as active treatment in acupuncture trials compared to placebo pills in pharmaceutical trials. Placebo response might be observed more frequently to placebo needles than to placebo pills. When acupuncture treatments are utilized in clinical use, placebo effects can be enhanced by exploiting patients' expectations in the contextual or environmental cues that surround medical intervention. Conclusions: We have to consider these unique characteristics of placebo needles in order to avoid drawing premature conclusions that acupuncture itself is just a placebo.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.21 no.2
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• pp.94-101
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• 2008

Objectives : To discuss the types of control groups in randomized controlled trials (RCTs) of herbal medicine, and to provide suggestions for improving the design of control group in future clinical trials. Methods : We reviewed the 8 articles about clinical trial design of Chinese herbal preparation which were published from 2005 through 2008. We selected those articles from CNKI(中國知識基礎施設工程(http://www.cnki.net)). Results : It is necessary to have control group in randomized controlled trials(RCTs) of Korean herbal preparation. But there are problems in the selection of appropriate control group drug. This paper lists several problems about the choice of control drug and puts forward some proposals and countermeasures. There are problems such as ethics and manufacturing matching placebo and positive control herbal drug. Conclusion : To improve the quality of control group design, we introduce standard drug plus placebo drug method and add-on research for placebo control group design, double dummy technique, using negative control drug or composite control drug for active control group design.

• Tuberculosis and Respiratory Diseases
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• v.85 no.1
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• pp.67-73
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• 2022

Background: Bronchiectasis patients with neutrophilic airway inflammation develop symptoms of chronic cough, sputum production, and recurrent exacerbations. Roflumilast has anti-inflammatory actions via decreased neutrophilic airway inflammation. The effectiveness of roflumilast to reduce bronchiectasis exacerbation has never been evaluated. Methods: We conducted a double-blinded, randomized, placebo-controlled trial. Our primary objective was to assess the effect of roflumilast compared with that of a placebo in reducing exacerbation rates in bronchiectasis patients. The secondary objectives were the changes in forced expiratory volume in 1 second (FEV₁) and St. George's Respiratory Questionnaire (SGRQ). Bronchiectasis patients older than 18 years who had had two exacerbations during the previous 12 months were randomly assigned to receive either 500 ㎍ of either roflumilast or a placebo once daily for 6 months in a 1:1 ratio. Results: Forty bronchiectasis patients who had experienced exacerbations were screened. Thirty patients completed the study after 6 months of treatment: roflumilast group (n=15) and placebo group (n=15). The rates of exacerbations were 0.57 and 0.59 per patient in the roflumilast and placebo groups, respectively. Prebronchodilator FEV₁ increased by 0.07 L from baseline in the roflumilast group and decreased by 0.015 L in the placebo group, but the difference was not significant. No significant differences were observed in the change of SGRQ scores between the roflumilast and placebo groups. Roflumilast had significant side effects, including loss of appetite and headache. Conclusion: Roflumilast did not significantly affect the rate of exacerbations or quality of life. However, FEV₁ tended to improve more in the roflumilast group than in the placebo group.

• Preventive Nutrition and Food Science
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• v.10 no.3
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• pp.285-289
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• 2005

In this double-blind, placebo-controlled trial, we assessed the efficacy and safety of beef tallow extract (BTE) including Cis-9-cetylmyristoleate in patients with arthritis. Between May and December 2003, we selected 80 patients (n=80) who showed/manifested arthritic symptoms and whose radiological findings were suggestive of arthritis, and randomly assigned them to placebo-controlled (n=40) and treatment group (n=40). The placebo (corn starch 350 mg) and BTE (208 mg) were orally administered to placebo-controlled and treatment group three times a day, respectively. We assessed the efficacy and safety based on the visual analogue scale (V AS) and modified knee society knee scores (MKSKS) at baseline and endpoint, respectively. To assess the safety, we monitored the adverse effects noted in liver, kidney, cardiovascular and gastrointestinal system for 3 weeks. Then, we performed not only a questionnaire study but also laboratory tests (e.g., liver function test, kidney function test, urinalysis, electrocardiography [EKG], complete blood cell counts [CBC] and chest X-ray). For statistical analysis, Student (-test and paired (-test were done using SPSS■ Version 11.0. Statistical significance was set at p < 0.05. The scores between V AS and MKSKS showed statistical significance (p < 0.05) with an improvement of $69.2\%$ (27/39) and $3.8\%$ (21/39) of treatment-group patients, respectively. Abnormal laboratory findings were noted in neither placebo-controlled nor treatment group. In conclusion, our results indicate that the administration of BTE was a safe and effective treatment regimen for patients with arthritis. In addition, the efficacy of BTE was more remarkable in alleviating the symptoms rather than improving the function.

• Korean Journal of Acupuncture
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• v.25 no.2
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• pp.57-69
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• 2008

Objectives : To review the controlling methods used in RCTs (randomized controlled trials) of auricular acupuncture. Methods : To investigate the controlling methods used in clinical trials of auricular acupuncture, 46 articles were retrieved from PUBMED (from August 1976 to August 2007, with limits: english, clinical trial) using the key words of "ear acupuncture", "auricular acupuncture", "auriculo-medicine", and sorted out according to the types of control treatments. Among them, 10 articles were selected based on STRICTA (Standards for Reporting Intervention in Controlled Trials of Acupuncture), and the controlling methods used in those articles were reviewed. Results : In clinical trials of auricular acupuncture, 'sham acupoints (non-acupoints and non-treatment acupoints included)', 'minimal acupuncture', 'pseudo-intervention', and 'placebo devices' have been used as controlling methods, but their 'inactivity' have been in question. To compensate the disadvantages of 'minimal acupuncture', and 'pseudo-intervention' control, placebo auricular acupuncture needles have been developed, although these needles didn't satisfy the conditions of 'blinding' and 'physical inactivity' simultaneously. Conclusions : Further researches on 'sham acupoints' and new development of 'placebo auricular acupuncture needles' are needed.

• Korean Journal of Acupuncture
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• v.23 no.1
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• pp.95-109
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• 2006

Objectives : There has been a considerable debate about how to best control for placebo effects in clinical trials of acupuncture. Recently several sham needles were developed and validated. This study aimed at summarising the validation studies of these needles and evaluating the outcomes of the randomised controlled trials (RCTs) using them. Methods : Computerised literature searches were performed using 'acupuncture' AND 'placebo OR sham' with a limitation of the results to RCTs in Medline via PubMed and the Cochrane Library. Only formally validated sham needle controlled studies were included. Data were extracted regarding study design, condition, sample size, credibility testing, intervention and outcomes. Methodological quality was assessed using a modified Jadad scale. Results : Three validated sham needles by Streitberger, Park, and Fink, were identified. Acupuncture's effectiveness for various conditions was tested using these needles in 12 RCTs. Real acupuncture was superior to sham acupuncture for rotator cuff tendonitis and hypertension. No significant differences between real acupuncture and sham acupuncture emerged for chemotherapy-related nausea and vomiting, postoperative nausea and vomiting, menstrually related migraine, acute stroke rehabilitation, chronic/episodic tension-type headache, neutrophil respiratory burst in healthy volunteers, alcohol withdrawal symptoms and chronic poststroke leg spasticity. Conclusions : The new sham devices have been adequately validated and may be useful tools for investigating specific research question. In spite of the sham needle's limits, the results of RCTs using such devices tend to suggest that the clinical effects of acupuncture are largely due to a placebo response.

• The Journal of Korean Physical Therapy
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• v.26 no.5
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• pp.331-343
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• 2014

Purpose: The purpose of this study is to assess the effectiveness of short-wave therapy (SWT) for treatment of knee osteoarthritis (OA) as compared to placebo and control, and to assess the question of whether the effects are related to the mode, dosage, and application method. Methods: We searched randomized, placebo-controlled trials using electronic databases. We also manually reviewed sources in order to identify additional relevant studies. Results: Eight studies (597 participants) with OA were included in the meta-analysis. Pulse SWT had a significant effect on pain relief compared with control treatment, while did not favour compared with the placebo group. Pulse SWT had a significant effect on functional improvement compared with control and placebo treatment. Continuous SWT had no effect on pain relief and functional improvement. Capacitive SWT a significant effect on pain relief, functional improvement, and muscle strength. Continuous and capacitive SWT had increased muscle strength significantly. We found no clinical significance of all outcomes except pain and functional improvement in pulsed SWT with low dose. There was no difference in adverse events. None of the participants experienced any serious adverse events. Conclusion: Low dose pulsed SWT provided a short-term clinical benefit for pain relief and functional improvement. Pulsed SWD with low and high dose had effects on pain and function. There seems to be a placebo effect. We found significant effects on pain and function in capacitive SWT. Despite some positive findings, this analysis lacked data on how effectiveness is affected by mode, dosage, and application method of SWT. Further well-designed clinical studies are required in order to confirm the effectiveness of SWT.